Quantia IgE— 510(k) K214068
Substantially EquivalentBiokit, S.A.
FDA 510(k) clearance K214068 for Quantia IgE, Substantially Equivalent on 2023-02-21. Applicant: Biokit, S.A.. Device class: 2.
Clearance details
- Applicant
- Biokit, S.A.
- Product code
- Code DGC
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Lliçà D´Amunt, ES
Recent devices under product code DGC
view all- K231151 — Kenota 1 Total IgE; Kenota 1 (instrument)
- K220178 — Total Immunoglobulin E (IgE)
- K193493 — ADVIA Centaur Total IgE (tIgE)
- K161899 — ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
- K133404 — IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
More clearances from Biokit, S.A.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.